Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
Public ClinicalTrials.gov record NCT00086177. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy, Safety, and Tolerability of 8% Progesterone Vaginal Gel in Preventing Preterm Delivery in Pregnant Women at Increased-Risk for Preterm Delivery
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication). Neither the investigators nor the patients in the trial will know which treatment has been assigned. All study medications will be given vaginally once a day. Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy week 36.
Study identification
- NCT ID
- NCT00086177
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 636 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2004 (Type not available)
- Primary completion
- Jan 2007 (Actual)
- Completion
- Mar 2009 (Actual)
- Last update posted
- Aug 19, 2010
2004 – 2009
United States locations
- U.S. sites
- 45
- U.S. states
- 22
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama Department of OBGYN | Mobile | Alabama | 36604 | — |
| Visions Clinical Research-Tucson | Tucson | Arizona | 85712 | — |
| Women's Health Department | Colton | California | 92324 | — |
| SanDiego Perinatal Center | San Diego | California | 92123 | — |
| Harbor - UCLA Medical Center | Torrance | California | 90509 | — |
| Kaiser Permanente | Denver | Colorado | 80205 | — |
| Northside Maternal Fetal Specialists | Atlanta | Georgia | 30342 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | — |
| Maternal Fetal Medicine Norton Suburban Hospital | Louisville | Kentucky | 40207 | — |
| Maternal Fetal Medicine &Woman's Health Research | Baton Rouge | Louisiana | 70815 | — |
| Louisiana State University Health Sciences Center-Shreveport | Shreveport | Louisiana | 71103 | — |
| Johns Hopkins Community Physicians | Baltimore | Maryland | 21211 | — |
| Holy Cross Hospital | Silver Springs | Maryland | 20910 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| St. Elizabeth's Medical Center -MFM | Brighton | Massachusetts | 02135 | — |
| St. Louis University | St Louis | Missouri | 63021 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Cooper University Hospital | Camden | New Jersey | 08103 | — |
| Department of OBGYN, St. Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| St. Luke's - Roosevelt Hospital | New York | New York | 10019 | — |
| Jacobi Medical Center | The Bronx | New York | 10461 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Pitt County Memorial Hospital | Greenville | North Carolina | 27834 | — |
| Lyndhurst Gynecologic Associates | Winston-Salem | North Carolina | 27103 | — |
| Ohio Permanente Medical Group | Bedford | Ohio | 44146 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| MacDonald Clinical Trials Unit, University Hospitals of Cleveland | Cleveland | Ohio | 44104-5034 | — |
| The Toledo Hospital | Toledo | Ohio | 43606 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Temple University Medical Center | Philadelphia | Pennsylvania | 19140 | — |
| Abington Primary Women's Healthcare | Willow Grove | Pennsylvania | 19090 | — |
| University Medical Group, Dept of OB/GYN | Greenville | South Carolina | 29605 | — |
| Regional Obstetrical Consultants | Chattanooga | Tennessee | 37403 | — |
| Gynecology & Obstetrics | Memphis | Tennessee | 38120 | — |
| Womens Partner In Health | Austin | Texas | 78705 | — |
| Health Central Women's Care | Dallas | Texas | 75231 | — |
| Clinical Research Center of Houston | Houston | Texas | 77054 | — |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | — |
| Texas Tech Health Sciences Center - Odessa | Odessa | Texas | 79763 | — |
| EVMS Maternal-Fetal Medicine, Hofheimer Hall | Norfolk | Virginia | 23507 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00086177, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2010 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00086177 live on ClinicalTrials.gov.